Medical Device Problem Reporting

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(No Transcript)
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Medical Device Problem Reporting A Saudi Food
Drug Authority Program
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Pioneering
Experienced
Independent
Medical Device Reporting January 2008 Joel J.
Nobel, MD. Founder President Emeritus
Evidence-based
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Reporting Medical Device Problems

• Why?
• Who?
• When?
• How?

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Why Report Medical Device Problems?

• Health professionals have a moral and ethical
  obligation to minimize harm to patients, improve
  their skills and support their hospitals pursuit
  of patient safety and quality of care
• Reporting medical device failures and related
  adverse effects helps identify and prevent
  similar events in the future
• Reporting allows analysis of cause and focused
  corrective action

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Why Report Medical Device Problems?

• Without reporting and sharing information health
  professionals, biomedical engineers, materials
  managers and procurement personnel are
  handicapped in selecting and purchasing medical
  products
• Without reporting health professionals may not be
  able to identify the need for additional training
  of physicians and nurses
• Without reporting the Saudi Food and Drug
  Authority cannot identify deficient products and
  prevent their import or sale and this increases
  the probability that hospitals will harm
  patients, waste time and money

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Why Report Medical Device Problems?

• Health professionals and hospitals need to
  minimize the risk of lawsuits by patients and
  families and loss of reputation caused by
  injuries and deaths related to medical devices
• Saudi suppliers and manufacturers need organized
  feedback to improve their judgment about
  products, processes, components and materials so
  they can deliver safer and higher quality
  products to hospitals and device users

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What Types of Adverse Events Are Caused by
Medical Devices?

• Injuries to patients and hospital personnel
• Deaths of patients and hospital personnel
• Environmental damage
• Lawsuits by patients or their families
• New expenses for repair or retraining
• Abandonment of a product and loss of the
  investment

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The Causes of Medical-Device-Related Incidents

• Device failure
• Device interaction
• User error
• Maintenance error
• Packaging error

• Tampering
• Support system failure
• Environmental factor
• Idiosyncratic patient reaction

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Typical Causes of Device Failure

• Design/labeling error
• Manufacturing error
• Software deficiency
• Random component failure
• Power-supply failure
• Failure of accessory

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Mechanisms of Device Related Injury Death

• Overdose
• Suffocation/barotrauma
• Infection
• Embolism (gas/particulate)
• Skin lesion (puncture/cut/burn

• Electrocution
• Fire
• Performance failure
• Crushing
• Exsanguination

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Most Frequently Reported Harmful Devices

• Anesthesia machines
• Cardiac interventional catheters
• Cardiopulmonary bypass systems
• Defibrillators
• Dialysis systems

• Electrosurgical (surgical diathermy) units
• Disposable surgical trocars
• IV pumps
• Surgical staplers
• Ventilators

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Observation

• Of these top 10 harmful devices, half (5) are
  used only in the operating theatre.
• 3 additional ones may be used in the operating
  theatre.
• 3 are used in almost all areas of the hospital.
• The most frequently reported problem device is
  the infusion pump.
• 3 of the 10 devices are highly dependent on
  physician technique with very simple devices
  (i.e., interventional catheters, trocars, and
  staplers)

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Conclusion

• 7 of these 10 devices require main voltage
  electrical energy.
• But in 6 of these 7 devices, almost all reported
  problems are mechanical.
• One device, the defibrillator, has frequently
  reported battery- and power-supply problems
  (i.e., too little rather than too much
  electricity).
• Focus attention on mechanical problems because
  the electrical safety issues are highly
  exaggerated.
• Maintenance error or failure to inspect is rarely
  a cause of harm.
• Focus attention on training because most harm
  involving devices is caused by operator error.

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What Inhibits Reporting of Medical Device Adverse
Events?

• Perception of the event
• Information-sharing culture
• Fear of authoritarian superiors
• Fear of blame and punishment
• Lack of a general incident reporting system,
  (critical to risk management)
• Failure to investigate the event and incorporate
  what was learned into training, revised clinical
  procedures and more effective selection and
  procurement of medical devices

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Educate Device Users

• Have them
• Explore www.mdsr.ecri.org
• Read case histories of deaths and injuries caused
  by devices they use in their specialty and why
  they occurred
• Download and publicize safety posters for
  specific devices

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Who Should Report?

• It depends on the incident reporting system and
  reporting channels in your hospital
• In most Western hospitals reporting is done by
  the nursing staff through the incident reporting
  system and the incident comes to the attention of
  the risk management department and biomedical
  engineering department
• Typically the risk manger or biomedical engineer
  reports the incident to the device regulatory
  agency

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When?

• As quickly as possible before memories fade
• While the scene of the incident and evidence is
  preserved so the risk manager and biomedical
  engineer can examine the device, take notes and
  if appropriate take photographs and try to
  determine the cause

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Protect the Patient Staff, But Preserve the
Evidence!

• The first priority is to prevent further harm to
  patient or staff
• The next highest priority is to protect the
  physical environment e.g. from fire
• The last critical priority is to preserve the
  evidence so cause can be determined

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Preserve the Evidence for Analysis

• Do not move equipment, or accessories unless
  needed to project patient or staff from harm
• Treat the location of the event as if it were a
  crime scene
• Do not changes control settings on any equipment
• Do not detach or dispose of any accessories or
  consumables or single use products such as
  cables, catheters, electrodes. tubes,
  humidifiers, etc. Their presence, juxtaposition
  and connections may prove critical in
  understanding the event
• Make sketches or take photographs as appropriate
• Document who was there, who did what, what
  happened. etc.

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Things Not To Do

• Never, ever send or release implicated devices
  to suppliers or manufacturers until the analysis
  is complete and cause is determined. Once the
  device is out of your control it can be altered
  or be lost
• Do not assume that suppliers are on your side. If
  investigation requires the help of the supplier
  be sure it is done in the hospital with your risk
  manager, biomedical engineer and involved health
  professionals and, if you wish, a representative
  of the SFDA present
• Do not assume, once you have completed your
  investigation, that nothing else need be done. If
  litigation is possible lock the device and its
  accessories in an area with controlled access and
  preserve it and related documentation and
  photographs as if it will undergo additional
  analysis and be introduced as evidence in court

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Things to Do

• Prevent adverse events by carefully selecting and
  purchasing medical devices. You now have
  immediate access to the most comprehensive
  up-to-date information in the world on the
  quality, safety and cost-effectiveness of such
  products via SFDA and ECRI
• When choosing equipment give special attention to
  ergonomics and human factors design (aviation
  examples)
• Emphasize training and retraining
• Share information openly

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How?

• We will now demonstrate
• How to report a medical device event to the
  Saudi Food Drug Authority
• How to search SFDA-ECRI supplied databases for
  adverse event information
• How to use SFDA-ECRI supplied databases to
  improve selection and procurement of medical
  devices

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Thank You or Questions